This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the gore® viabahn® vbx balloon expandable endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5mm - 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.
| Device | GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS |
| Classification Name | Iliac Covered Stent, Arterial |
| Generic Name | Iliac Covered Stent, Arterial |
| Applicant | W. L. Gore & Associates, Inc. |
| Date Received | 2016-07-05 |
| Decision Date | 2017-01-27 |
| Notice Date | 2017-02-27 |
| PMA | P160021 |
| Supplement | S |
| Product Code | PRL |
| Docket Number | 16M-0560 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W. L. Gore & Associates, Inc. 3250 West Kiltie Lane flagstaff, AZ 86005 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160021 | Original Filing | |
| S036 | 2022-12-15 | 30-day Notice |
| S035 | 2022-06-08 | 30-day Notice |
| S034 | 2022-02-11 | 30-day Notice |
| S033 | 2022-01-20 | 30-day Notice |
| S032 | 2021-07-30 | 30-day Notice |
| S031 | 2021-03-01 | 30-day Notice |
| S030 | 2021-02-25 | 30-day Notice |
| S029 | ||
| S028 | ||
| S027 | 2021-01-13 | 30-day Notice |
| S026 | 2020-03-13 | 30-day Notice |
| S025 | 2020-01-03 | 30-day Notice |
| S024 | ||
| S023 | 2019-06-07 | Normal 180 Day Track No User Fee |
| S022 | 2019-04-26 | 30-day Notice |
| S021 | 2019-04-15 | 30-day Notice |
| S020 | ||
| S019 | 2019-03-01 | 30-day Notice |
| S018 | 2019-03-01 | 30-day Notice |
| S017 | 2019-02-04 | 30-day Notice |
| S016 | ||
| S015 | 2018-11-15 | 30-day Notice |
| S014 | 2018-09-18 | 30-day Notice |
| S013 | 2018-08-24 | 30-day Notice |
| S012 | 2018-07-26 | 30-day Notice |
| S011 | 2018-06-29 | 30-day Notice |
| S010 | 2018-06-07 | 30-day Notice |
| S009 | 2018-05-25 | 30-day Notice |
| S008 | 2018-05-03 | 30-day Notice |
| S007 | ||
| S006 | 2018-04-17 | 30-day Notice |
| S005 | 2018-02-01 | 30-day Notice |
| S004 | 2017-07-17 | 30-day Notice |
| S003 | 2017-07-05 | 30-day Notice |
| S002 | 2017-05-26 | 30-day Notice |
| S001 |